Study on the Safety and Effects of THOR-707 in Adults with Advanced or Metastatic Solid Tumors
Sponsor: Synthorx, Inc, a Sanofi company
ClinicalTrials ID:NCT04009681
This clinical trial is testing a new drug, THOR-707, to see if it is safe and effective in treating adults with advanced or metastatic solid tumors. The study will explore how well the drug works alone and in combination with other treatments.
Patient Parameters
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Program Overview
The main goal of this study is to determine if THOR-707 is safe and well-tolerated when used alone or with other treatments in adults with advanced or metastatic solid tumors. Researchers will also identify the best dose for future studies and evaluate the drug's ability to shrink tumors. Participants will be monitored for any side effects and the overall effectiveness of the treatment over approximately 24 months.
Description
Participants in this study will receive the drug THOR-707, either by itself or combined with other treatments, to assess its safety and effectiveness. The study will last about 24 months for each participant, including follow-up visits. Researchers will look at how the drug affects tumor size and monitor for any side effects. The study has several parts, with some already completed, and will continue to explore the best dose and treatment combinations for future research.
Eligibility Criteria
Inclusion Criteria
- Have a measurable tumor that can be tracked using standard criteria.
- Have a life expectancy of at least 12 weeks.
- For certain parts of the study, participants should not have previously received PD-1 inhibitors, unless discussed with the study team.
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate heart, blood, liver, and kidney function.
- Have a confirmed diagnosis of advanced or metastatic solid tumors with at least one tumor that can be safely biopsied.
- For specific groups, have certain types of cancer or previous treatments as outlined by the study.
- Have no standard treatment options available, or have refused or not tolerated standard treatments.
- Women of childbearing potential and men must agree to use effective birth control during the study and for a specified time after the last dose.
- Women must have a negative pregnancy test before starting treatment.
- Men must agree not to donate sperm during the study and for a specified time after the last dose.
- In Spain, Chile, and Argentina, only certain groups will be open for enrollment.
Exclusion Criteria
- Have received radiation therapy or certain cancer treatments within a specified time before starting the study drug.
- Have had severe side effects from previous cancer treatments.
- Have had major surgery recently or need major surgery during the study.
- Have active autoimmune diseases requiring treatment or a history of severe autoimmune diseases.
- Have untreated or active brain cancer unless stable and not requiring certain medications.
- Have lung issues or require oxygen therapy.
- Have had recent infections requiring antibiotics.
- Have a history of organ transplants.
- Have uncontrolled diabetes or other immune-related conditions.
- Have active infections like HIV or hepatitis C.
- Have uncontrolled hepatitis B unless treated and stable.
- Have received a live vaccine recently.
- Have had significant bleeding or blood clots recently.
- Have severe heart conditions or uncontrolled high blood pressure.
- Have allergies to components of the study drug.
- Have another active cancer or a history of cancer that affects study assessments.
- Have any serious medical or psychiatric conditions that would interfere with the study.
- Are pregnant, breastfeeding, or planning to conceive during the study.
- Are participating in another clinical trial with a treatment component.
- For certain groups, have specific eye conditions or low oxygen levels.
- For specific groups, have certain types of melanoma.
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